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pharmacovigilance meddra sae susar signal detection📋 Description
- Serve as the medical safety lead across BlueRock's clinical trial portfolio
- Lead SAE/SUSAR assessments and causality determinations
- Own safety signal detection and aggregate safety reviews
- Prepare safety sections for protocols, SAPs, CSRs, and DSURs
- Oversee safety vendor selection and PV operations
- Ensure global safety reporting compliance and inspection readiness
🎯 Requirements
- MD (or equivalent) required; active clinical training valued
- 5+ years pharma/biotech drug safety and pharmacovigilance experience
- Strong knowledge of FDA/EMA safety regulations; ICH E2 familiarity
- Hands-on SAE narratives, MedDRA coding, signal detection
- Lean, matrixed environment: builder mindset
- Excellent written and verbal communication; interest in cell/gene therapy a plus
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